A Study of Montelukast (MK-0476) Compared With Fluticasone in Pediatric Participants With Chronic Asthma (MK-0476-303)

Overview

A study to determine the effects of montelukast (MK-0476) on pediatric participants with chronic asthma compared with fluticasone. The primary hypotheses are that, over 24 weeks of treatment, montelukast will provide at least the same level of asthma control as inhaled fluticasone as measured by the percentage of days without asthma and that, over 24 weeks of treatment, daily administration of montelukast will be safe and well tolerated in children aged 6 months to 5 years with chronic asthma. This trial was stopped at a time before any participants had actually entered the trial. Based on input from regulatory agencies, it is not necessary to conduct this study; a separate ongoing study was sufficient for regulatory purposes.

Full Title of Study: “A Phase III Double-Blind, Randomized, Placebo-Controlled Clinical Trial to Prospectively Evaluate Efficacy of Montelukast in Patients Aged 6 Months to 5 Years With Chronic Asthma”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Triple (Participant, Care Provider, Investigator)
  • Study Primary Completion Date: March 2008

Detailed Description

This study consists of a 4-week placebo run-in period followed by a 24-week double-blind treatment period.

Interventions

  • Drug: Montelukast sodium
    • Montelukast 4 mg OG or montelukast 4 mg CT
  • Drug: Placebo to montelukast
    • Placebo OG or CT
  • Drug: Fluticasone propionate
    • Fluticasone 50 mcg inhalation aerosol metered dose inhaler
  • Drug: Placebo to fluticasone
    • Placebo inhalation aerosol metered dose inhaler

Arms, Groups and Cohorts

  • Experimental: Montelukast
    • Participants receive montelukast 4 mg oral granules (OG) or 4 mg chewable tablets (CT) once daily (QD) for 24 weeks and placebo to fluticasone 50 mcg inhalation aerosol twice daily (BID) for 24 weeks. Participants aged >6 months to <2 years receive montelukast 4 mg packet of OG QD for 24 weeks. Participants aged >2 years to <64 months receive montelukast 4 mg CT QD for 24 weeks.
  • Active Comparator: Fluticasone
    • Participants receive fluticasone 50 mcg inhalation aerosol twice daily (BID) for 24 weeks and placebo to montelukast 4 mg QD for 24 weeks. Participants aged >6 months to <2 years receive placebo packet of OG QD for 24 weeks. Participants aged >2 years to <64 months receive placebo CT QD for 24 weeks.

Clinical Trial Outcome Measures

Primary Measures

  • Percentage of days without asthma
    • Time Frame: 24 weeks
    • A day without asthma is defined as a day with all of the following: no daytime symptoms, no nighttime cough, no β-agonist use, and no asthma attack (defined as a visit to a doctor, urgent care clinic, emergency room, or hospital for asthma [other than a scheduled visit to a doctor], or treatment with systemic corticosteroid during the previous 24 hours).
  • Number of participants who experience at least one adverse event (AE)
    • Time Frame: Up to 26 weeks
  • Number of participants who discontinue study drug due to an AE
    • Time Frame: Up to 24 weeks

Secondary Measures

  • Percentage of days without daytime symptoms
    • Time Frame: 24 weeks
  • Percentage of days without nighttime cough
    • Time Frame: 24 weeks
  • Percentage of days without β-agonist use
    • Time Frame: 24 weeks

Participating in This Clinical Trial

Inclusion Criteria

  • Between 6 months and 5 years, 4 months of age – Diagnosed with asthma by a doctor – At least 3 episodes of asthma symptoms within the last 6 months Exclusion Criteria:

  • Active or chronic breathing disease, other than asthma – Required insertion of a breathing tube for asthma – Major surgery within the last 4 weeks – Currently in the hospital – Allergic to certain drugs, and for children under 2 years of age, apples, applesauce and formula

Gender Eligibility: All

Minimum Age: 6 Months

Maximum Age: 5 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Organon and Co
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Medical Director, Study Director, Merck Sharp & Dohme LLC

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